Recall Z-1266-2013— Spinal Elements, Inc

Name: FDA recall Z-1266-2013
Creator: U.S. Food and Drug Administration
Published: 2009-04-17

Class III · Terminated

Class III FDA medical device recall by Spinal Elements, Inc, initiated 2009-04-17, terminated 2013-05-07. It names one FDA 510(k) clearance: K071914. Product: Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.. Reason: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue..

Recalling firm: Spinal Elements, Inc
Classification: Class III
Status: Terminated
Initiated: 2009-04-17
Terminated: 2013-05-07
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071914 — MERCURY SPINAL SYSTEMSpinal Elements, Inc.·cleared 2007-10-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Reason for recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.